To all:
I am following angiogenesis (positive and negative approach) for the last few years. Scios is company which is heavily involved in *therapeutic angiogenesis* (bFGF, VEGF124), so it was in my screen for some time.
Several weeks ago initiated position and bought few Apr. calls. At this time my position is based on expectation that Natrecor AC meeting in January will have positive outcome, but also am looking far beyond this point.
Do not remember that anyone posted report from Florida (Heart Failure Society) on neseritide (Natrecor) PIII safety trial:
<< SOURCE: Heart Failure Society of America
Cardiac Hormone Studies Show Clinical and Cost-Effectiveness Advantages for Treatment of Acute CHF
Data Presented at Second Annual Heart Failure Society of America Meeting
BOCA RATON, Fla., Sept. 16 /PRNewswire/ -- At scientific sessions today, investigators presented data on the genetically-engineered version of the cardiac hormone BNP (b-type natriuretic peptide) known as nesiritide. In separate presentations, investigators reported that clinical study data comparing the effect of nesiritide to dobutamine in patients hospitalized with acute congestive heart failure (CHF) showed that treatment with nesiritide was associated with a lower
incidence of dangerous cardiac arrhythmias and a shortened course of
intravenous therapy.
The studies were presented today at the second annual scientific meeting of the Heart Failure Society of America by Marc
Silver, M.D., Director, Heart Failure Institute, Christ Hospital Medical Center, Oaklawn, IL, and Andrew Burger, M.D., Beth
Israel Deaconess Medical Center, Boston, MA.
Dr. Silver's study, evaluating outcomes of hospitalized patients with
acute CHF receiving either nesiritide or the commonly-used
inotrope dobutamine, found that in patients treated with nesiritide,
intravenous administration could be discontinued as much as
one to two days earlier than in patients treated with dobutamine. Once
released from the hospital, patients receiving dobutamine
were also readmitted for CHF three times as often as patients receiving nesiritide (13 percent of dobutamine patients versus
four percent of nesiritide patients).
''Our study found that, compared to dobutamine, nesiritide decreased the likelihood that patients would be readmitted once
released from the hospital,'' Dr. Silver said. ''This suggests that
treating acute CHF patients with nesiritide may lead to lower
healthcare utilization costs than we see with dobutamine.''
The study reported by Dr. Burger evaluated the frequency of cardiac
arrhythmias associated with nesiritide and dobutamine.
Dobutamine was associated with more ventricular tachycardia (22 versus
eight percent of patients) and cardiac arrest (five
versus zero percent of patients) than nesiritide (0.03 ug/kg/min).
Dr. Silver noted that dose-related decreases in blood pressure, an
extension of nesiritide's effect as a vasodilator, were seen in
the trials but were manageable through dose reduction.
''It's clear that nesiritide will be a very important new member of the treatment-arsenal for patients admitted with acute
congestive heart failure,'' said Dr. Silver. ''The next step is to
evaluate how we may be able to use nesiritide to prevent patients
from being admitted to the hospital in the first place.''
Nesiritide is a genetically-engineered form of the naturally-occurring
hormone known as BNP (b-type natriuretic peptide), a hormone secreted by the ventricles of the heart as one of the body's natural responses to heart failure. It appears to help the body restore salt and water balance, and to improve the function of the heart. Dobutamine is an inotrope, a drug given to improve the heart's contractile function, frequently administered to individuals with acute CHF.
CONGESTIVE HEART FAILURE
Congestive heart failure (CHF) is a condition in which the heart can no longer pump enough blood to meet the needs of the
body's other organs. This decreased pumping ability, and therefore
reduced circulation, can have many consequences, such as:
shortness of breath, tiredness, difficulty sleeping, swelling of the
extremities, dry cough, and sudden weight gain (2-5 pounds in
1-4 days).
Congestive heart failure affects an estimated 4.9 million Americans,
with nearly one million hospitalized with acute CHF each
year. In 1998, Americans will spend an estimated $18.8 billion for the
care of CHF patients in hospitals, doctors' offices, home
care and nursing homes. Treatment for CHF accounts for more than five
percent of the total health care costs in the United States each year.
The Heart Failure Society of America (HFSA) was established in 1995 and represents the first organized effort by heart failure
experts from the Americas to provide a forum for medical personnel
focused on congestive heart failure research and patient care.
SOURCE: Heart Failure Society of America>>
Based on data from first efficiency Natrecor PIII trial, and this safety profile from second PIII trial (where Natrecor was administrated with current CHF drugs, doctors choice) compared with dobutamine (standard inotropic drug for acute CHF), I think that Natrecor chance to be recommended are very good.
However, my main interest is on FIBLAST (basic FGF) for coronary artery and peripheral vascular diseases and stroke. Was very disappointed after US PII/III stroke trials was halted.
Does anyone have more (specific) data about drug side effects in this trial?
What type of side effects (or toxicity) related to drug they observed in this trial?
Stroke is accompanied/caused with/by other diseases, so are this pts condition in trial entry reasons for observed toxicity?
TIA
Miljenko
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